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eudamed_udi Primary ID: 09349458005689

BOND-MAX Processing Module Laboratory - Automated Slide Stainer (UDI 09349458005689)

Manufactured by Leica Biosystems Melbourne Pty Ltd

Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BOND-MAX Processing Module Laboratory - Automated Slide Stainer - Primary ID 09349458005689

Device Regulatory Overview

The BOND-MAX Processing Module Laboratory - Automated Slide Stainer (Model/Catalog Number: RS49.0051) is a medical device manufactured by Leica Biosystems Melbourne Pty Ltd. This product is indexed under FDA Product Code / Category Classification W0202059002 within international Unique Device Identification (UDI) compliance databases.

ACTIVE SAFETY RECALL ALERT 1 Event(s) Found

Enforcement actions are currently active for this product line.

ID: Z-1683-2025 View Full Alert →

HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor...

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Technical Specifications

Model Number
RS49.0051
Product Code / EMDN
W0202059002
Device Name
BOND Processing Module
Database Sync Date
2026-08-09 17:15:11

Full Regulatory Attributes

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{
    "review_panel": "AN",
    "gudid_di_status": "Published",
    "sterilization_methods": ["EO", "Gamma"],
    "rx_only": true
}

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Frequently Asked Questions

Who is the primary manufacturer of BOND-MAX Processing Module Laboratory - Automated Slide Stainer?

The registered manufacturer of record for BOND-MAX Processing Module Laboratory - Automated Slide Stainer is Leica Biosystems Melbourne Pty Ltd.

What is the Primary UDI-DI identifier for BOND-MAX Processing Module Laboratory - Automated Slide Stainer?

The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 09349458005689.

What classification code is assigned to this device?

This device is registered under product classification code W0202059002.

Similar Classification Devices (W0202059002)

Other Devices by Leica Biosystems Melbourne Pty Ltd

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